Back to resultsEfficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain (PROGEL)
Primary Purpose
Musculoskeletal Pain, Acute Pain, Stretch
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ibuprofen gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring ibuprofen, ibuprofen gel, pain
Eligibility Criteria
Inclusion Criteria:
- Have signed the informed consent form;
- Participants of both genders aged ≥ 18 years;
- Present acute musculoskeletal pain as a result of: ankle sprains, upper limb contusions, thigh muscle sprains, or torticollis;
- Present pain of moderate intensity by VAS scale (3 ≤ VAS ≤ 7);
- Pain onset time is less than 36 hours;
- Present intact skin at the trauma site;
- Participants of both sexes with the potential to become pregnant must be truly abstinent or use a highly effective method of contraception throughout the period of 30 days before the administration of the drug until 30 days after the end of treatment;
- Agree to safety laboratory tests: pregnancy test, complete blood count, and biochemical profile;
- Be able to understand the nature and purpose of the trial, including the risks and adverse events.
Exclusion Criteria:
- Participants under the age of 18;
- Participants with musculoskeletal pain as a result of fractures or dislocations;
- Participants with mild pain (VAS < 3) at the time of selection;
- Participants with severe pain (VAS > 7) at the time of selection;
- Participants with pain onset time greater than 36 hours;
- Participants with a history of chronic pain and acute pain spikes;
- Participants with loss of skin integrity at the trauma site;
- Have a known hypersensitivity reaction to the trial medication or chemically related compounds;
- Have a prior history of the following comorbidities: asthma or other allergic conditions, uncontrolled heart failure, chronic kidney disease, chronic liver disease, active peptic ulcer disease, or gastrointestinal bleeding;
- Suspect for COVID-19 according to the criteria defined by the World Health Organization;
- Regular use of analgesics, non-steroidal analgesics or anticoagulants;
- Use of oral or topical corticoids in the injured area;
- Being on medications that have relevant interactions with the trial drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, lithium, methotrexate, acetylsalicylic acid, corticosteroids, oral hypoglycemic agents, beta blockers, angiotensin-converting enzyme inhibitors, antihypertensive agents, and diuretics such as furosemide or thiazide;
- Have had oral or topical analgesic treatment, including use of non-steroidal analgesics, within 72 hours prior to the screening visit;
- Participants using traditional Chinese or Japanese therapy (acupuncture);
- Abusive use of alcoholic beverages;
- Women who are pregnant, breastfeeding, planning to become pregnant, or who test positive for pregnancy during the trial period;
- Have participated in a clinical trial within the last 12 months;
- Have any condition that would preclude participation in the trial in the physician's judgment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ibuprofen gel 5%
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain.
The primary endpoint of the study is the proportion of participants achieving at least 50% pain reduction on day 5 of treatment by assessing pain intensity using the Visual Analog Scale (VAS), compared to baseline VAS. (Scale = 0 to 10; 0 = mild pain and 10 = severe pain)
Secondary Outcome Measures
Pain relief with study medication on days 3, 5, and 7.
Pain relief by the adapted Pain Relief (PAR) Scale, with the 5 categories: 0 - no relief, 1- slight relief, 2 - moderate relief, 3 - considerable relief, and 4 - complete relief, on days 3, 5, and 7.
Interference of pain on physical activity on days 3, 5 and 7
Pain interference with physical activity by 4-point scale: 0 - no interference with physical activity; 1 - no restriction of physical activity, although some pain on movement; 2 - some restriction of physical activity, but not enough to prevent normal activity; 3 - unable to perform normal activities and with substantial limiting effects, on days 3, 5, and 7.
Time needed for pain improvement.
Time needed for pain improvement (reduction of at least 50% of pain on the VAS scale)
Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment.
Overall assessment of treatment by participant using 5-point scale: bad, fair, good, very good, and excellent.
Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment.
Overall assessment of treatment by physician using 5-point scale: bad, fair, good, very good, and excellent.
Number of participants using rescue medication.
Time to use of rescue medication.
Full Information
NCT ID
NCT05013567
First Posted
August 3, 2021
Last Updated
March 17, 2022
Sponsor
Brainfarma Industria Química e Farmacêutica S/A
1. Study Identification
Unique Protocol Identification Number
NCT05013567
Brief Title
Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain
Acronym
PROGEL
Official Title
Randomized, Double-Blind, Parallel, Phase III Superiority Clinical Trial to Evaluate the Efficacy and Safety of Ibuprofen Gel Compared With Placebo in the Treatment of Acute Musculoskeletal Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainfarma Industria Química e Farmacêutica S/A
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.
Detailed Description
This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves.
It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis.
The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Acute Pain, Stretch, Sprains
Keywords
ibuprofen, ibuprofen gel, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen gel 5%
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen gel
Intervention Description
Ibuprofen gel 5% topically four times a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo gel topically four times a day
Primary Outcome Measure Information:
Title
Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain.
Description
The primary endpoint of the study is the proportion of participants achieving at least 50% pain reduction on day 5 of treatment by assessing pain intensity using the Visual Analog Scale (VAS), compared to baseline VAS. (Scale = 0 to 10; 0 = mild pain and 10 = severe pain)
Time Frame
5 days of treatment
Secondary Outcome Measure Information:
Title
Pain relief with study medication on days 3, 5, and 7.
Description
Pain relief by the adapted Pain Relief (PAR) Scale, with the 5 categories: 0 - no relief, 1- slight relief, 2 - moderate relief, 3 - considerable relief, and 4 - complete relief, on days 3, 5, and 7.
Time Frame
3, 5 and 7 days of treatment
Title
Interference of pain on physical activity on days 3, 5 and 7
Description
Pain interference with physical activity by 4-point scale: 0 - no interference with physical activity; 1 - no restriction of physical activity, although some pain on movement; 2 - some restriction of physical activity, but not enough to prevent normal activity; 3 - unable to perform normal activities and with substantial limiting effects, on days 3, 5, and 7.
Time Frame
3, 5 and 7 days of treatment
Title
Time needed for pain improvement.
Description
Time needed for pain improvement (reduction of at least 50% of pain on the VAS scale)
Time Frame
Through study completion, an average of 7 days
Title
Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment.
Description
Overall assessment of treatment by participant using 5-point scale: bad, fair, good, very good, and excellent.
Time Frame
Through study completion, an average of 7 days
Title
Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment.
Description
Overall assessment of treatment by physician using 5-point scale: bad, fair, good, very good, and excellent.
Time Frame
Through study completion, an average of 7 days
Title
Number of participants using rescue medication.
Time Frame
Through study completion, an average of 7 days
Title
Time to use of rescue medication.
Time Frame
Through study completion, an average of 7 days
Other Pre-specified Outcome Measures:
Title
Occurrence of adverse events (AEs) during the study period.
Description
Rate of occurrence of serious and non-serious AEs, related and unrelated to treatment groups throughout the clinical trial.
Time Frame
Through study completion, an average of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have signed the informed consent form;
Participants of both genders aged ≥ 18 years;
Present acute musculoskeletal pain as a result of: ankle sprains, upper limb contusions, thigh muscle sprains, or torticollis;
Present pain of moderate intensity by VAS scale (3 ≤ VAS ≤ 7);
Pain onset time is less than 36 hours;
Present intact skin at the trauma site;
Participants of both sexes with the potential to become pregnant must be truly abstinent or use a highly effective method of contraception throughout the period of 30 days before the administration of the drug until 30 days after the end of treatment;
Agree to safety laboratory tests: pregnancy test, complete blood count, and biochemical profile;
Be able to understand the nature and purpose of the trial, including the risks and adverse events.
Exclusion Criteria:
Participants under the age of 18;
Participants with musculoskeletal pain as a result of fractures or dislocations;
Participants with mild pain (VAS < 3) at the time of selection;
Participants with severe pain (VAS > 7) at the time of selection;
Participants with pain onset time greater than 36 hours;
Participants with a history of chronic pain and acute pain spikes;
Participants with loss of skin integrity at the trauma site;
Have a known hypersensitivity reaction to the trial medication or chemically related compounds;
Have a prior history of the following comorbidities: asthma or other allergic conditions, uncontrolled heart failure, chronic kidney disease, chronic liver disease, active peptic ulcer disease, or gastrointestinal bleeding;
Suspect for COVID-19 according to the criteria defined by the World Health Organization;
Regular use of analgesics, non-steroidal analgesics or anticoagulants;
Use of oral or topical corticoids in the injured area;
Being on medications that have relevant interactions with the trial drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, lithium, methotrexate, acetylsalicylic acid, corticosteroids, oral hypoglycemic agents, beta blockers, angiotensin-converting enzyme inhibitors, antihypertensive agents, and diuretics such as furosemide or thiazide;
Have had oral or topical analgesic treatment, including use of non-steroidal analgesics, within 72 hours prior to the screening visit;
Participants using traditional Chinese or Japanese therapy (acupuncture);
Abusive use of alcoholic beverages;
Women who are pregnant, breastfeeding, planning to become pregnant, or who test positive for pregnancy during the trial period;
Have participated in a clinical trial within the last 12 months;
Have any condition that would preclude participation in the trial in the physician's judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cosmed Indústria de Cosméticos e Medicamentos S/A
Phone
5511 45072111
Email
juliana.augusto@brainfarma.ind.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brainfarma Indústria Química Farmacêutica
Organizational Affiliation
Brainfarma Industria Química e Farmacêutica S/A
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain
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